The Delhi High Court upheld the rejection of a patent application for 'Co-crystals of Tramadol and Coxibs' for lack of inventive step, while affirming novelty. The tiered analysis clarifies patent examination sequence.
Delhi HC Upholds Patent Rejection in Esteve Pharmaceuticals Case
The Delhi High Court in Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs (2026) applied a tiered approach to evaluating patentability, affirming the rejection of a patent application for 'Co-crystals of Tramadol and Coxibs' on grounds of inventive step under Section 2(1)(ja) of the Patents Act, 1970. While holding that the invention satisfied the threshold for novelty under Section 2(1)(j), the court concluded it did not demonstrate a technical advance over prior art.
The tiered methodology adopted by the court separates the examination of novelty, inventive step, and industrial applicability into distinct stages. This structured review ensures that applications are not dismissed summarily without assessing each statutory requirement independently. The court emphasized that failure at any stage — even after establishing novelty — is fatal to grant of a patent.
The judgment clarifies that co-crystal formulations, while chemically novel, may still fall short if they do not produce unexpected or synergistic therapeutic effects. The court relied on experimental data and prior disclosures involving similar NSAID combinations to conclude that the claimed improvement was obvious to a person skilled in the art.
Practitioners should take note that patent offices and courts will increasingly apply rigorous, stage-wise scrutiny in pharmaceutical patents. Applications involving polymorphic forms, salts, or co-crystals must now include robust data demonstrating non-obviousness and enhanced efficacy. This decision sets a precedent for future appeals before the IPAB and civil courts.
Citations
- Esteve Pharmaceuticals S.A. v. CPD (2026) Delhi HC
